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    Summary
    EudraCT Number:2021-005787-22
    Sponsor's Protocol Code Number:EP395-003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-06-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2021-005787-22
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled study to investigate the safety and tolerability of EP395 in patients with chronic obstructive pulmonary disease (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to study the safety and tolerability of EP395 in comparison with placebo in patients with chronic obstructive pulmonary disease (COPD)
    A.4.1Sponsor's protocol code numberEP395-003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEpiEndo Pharmaceuticals
    B.1.3.4CountryIceland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEpiEndo Pharmaceuticals
    B.4.2CountryIceland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEpiEndo Pharmaceuticals
    B.5.2Functional name of contact pointProject Manager Kate Hanrott
    B.5.3 Address:
    B.5.3.1Street AddressBjargargata 1
    B.5.3.2Town/ cityReykjavík
    B.5.3.3Post code102
    B.5.3.4CountryIceland
    B.5.4Telephone number+447811215958
    B.5.6E-mailkate@epiendo.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code EP395
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNn.a.
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeEP395
    D.3.9.3Other descriptive nameEP395
    D.3.9.4EV Substance CodeSUB269486
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic obstructive pulmonary disease (COPD)
    E.1.1.1Medical condition in easily understood language
    Lung conditions that cause breathing difficulties (COPD)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of repeat doses of EP395 in patients with COPD
    E.2.2Secondary objectives of the trial
    Secondary objectives:

    • To assess the effect of EP395 on lung inflammation
    • To assess the effect of EP395 on systemic inflammation
    • To assess the effect of EP395 on lung function
    • To assess the systemic exposure to EP395
    • To assess the effect of EP395 on quality of life

    Exploratory objectives:
    • To assess the effect of EP395 on mechanistic biomarkers
    • To assess the effects of EP395 on the microbiome
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to understand the information on the nature, the scope, and the relevance of the study, and to provide voluntary, written informed consent to participate in the study before any study-related procedures
    2. Men and women, aged ≥45 years
    3. Women of childbearing potential must:
    a. have a negative pregnancy test (blood) at Screening and (urine) Day 1
    b. agree to use, and be able to comply with, highly effective measures of contraceptive control (failure rate less than 1% per year when used consistently and correctly) without interruption, during study participation and until 90 days after the last investigational product (IP) intake.
    c. agree to abstain from breast feeding during the study participation and for 90 days after the last IP intake.
    4. Men must agree to use a condom during sexual intercourse with women of childbearing potential during treatment and for 90 days after the last IP intake and should not donate sperm during this time
    5. Diagnosed with COPD for at least 2 years with FEV1/forced vital capacity (FVC) ratio <0.70 and FEV1 <70% (post bronchodilator) at Screening
    6. Receiving at least one maintenance inhaled therapy (ie, LABA, LAMA, LABA/LAMA, LABA/ICS, LAMA/ICS, or LABA/LAMA/ICS) for at least 3 months before Screening
    7. Able to tolerate the sputum induction procedure and to produce an adequate (volume and sufficient quality for cell count) sputum sample
    8. Body mass index of ≥19 and ≤35 kg/m2
    9. History of sputum production (bronchitic phenotype) for approximately 3 months (minimum, not consecutive) in a year
    10. Up to date COVID-19 vaccination (according to local law and guidelines)
    E.4Principal exclusion criteria
    1. History or presence of any clinically relevant medical condition including laboratory test abnormality or planned surgery that in the investigator’s opinion could affect the patient’s safety or interfere with the objectives of the study
    2. Exacerbation of COPD in the 3 months before Screening
    3. Change in medication for COPD in the 3 months before Screening
    4. Lung function at Screening that in the investigator’s opinion would indicate not safe to perform sputum induction or bronchoscopy (bronchoscopy applicable only in a subset of patients)
    5. History of or active tuberculosis
    6. Malignancy within the past 5 years, except removed basal cell carcinoma and resected benign colonic polyps
    7. Clinically significant abnormality on 12-lead ECG including prolonged corrected QTcF (>450 msec in men or >470 msec in women); based on triplicate) at Screening and Day 1 pre-dose
    8. Absolute estimated glomerular filtration rate ([eGFR cystatin C + eGFR creatinine]/2) <60mL/min according to Lund-Malmö equation at Screening
    9. AST or ALT >1.5 x ULN at Screening
    10. Use (including prescription, over-the-counter, herbal or dietary) of cytochrome P450 (CYP) inducers within 28 days before first dosing, or strong or moderate inhibitors of CYP3A4 (including dietary eg, grapefruit juice) or P-glycoprotein (Pgp) inhibitors or oral narrow therapeutic index (TI) Pgp substrates (eg, digoxin) within 14 days before first dosing
    11. Use of macrolide, roflumilast, or oral corticosteroid (OCS) within 28 days before Screening
    12. Ongoing antibiotic treatment at Screening
    13. Use of home oxygen or home-based non-invasive ventilation 3 months before Screening
    14. Use of a biological therapy within 3 months before Screening
    15. Use of herbal remedies within 28 days before first dose until follow up
    16. Live vaccine within 28 days or any other vaccine within 14 days before first dose until 28 days after final dose of the IP (with the exception of COVID-19 booster and flu vaccination; see Previous and concomitant medications and therapies)
    17. Positive hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus 1 or 2 antibodies at Screening
    18. Positive test result for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) on Day 1
    19. Positive drugs of abuse test at Screening, including cotinine only in ex-smokers for at least 3 months
    20. Use of e-cigarettes and vapes
    21. History of alcohol or drug misuse within 12 months before Screening
    22. Pregnant and lactating women
    23. Prior recovery from recent infection, including but not limited to COVID 19 within the last 30 days before first dosing with IP
    24. Known hypersensitivity to macrolides or EP395 or any of the excipients (dicalcium phosphate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose)
    25. Participation in a study of an experimental drug within 5 half-lives or 3 months before Screening, whichever is longer
    26. Dependent subjects of the sponsor or investigator (eg, employees, relatives)
    27. Patients without the capacity to understand the nature and risks of the study
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events (AEs), vital signs, laboratory safety tests, 12-lead electrocardiograms (ECGs), physical examinations
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout treatment phase and follow-up
    E.5.2Secondary end point(s)
    1) Sputum cells (total and differential) and inflammatory mediators including interleukin (IL) 8, tumour necrosis factor (TNF)-α, IL-6, IL 1β, macrophage inflammatory protein (MIP) 1α, MIP-1β, monocyte chemotactic protein (MCP)-1, surfactant protein D (SP-D), granulocyte macrophage colony-stimulating factor (GM-CSF), IL-23, IL-33, IL-25, IL-10, neutrophil elastase (NE), matrix metalloproteinase (MMP)-9, CXC motif chemokine ligand (CXCL)1, myeloperoxidase (MPO)
    2) Blood inflammatory markers including fibrinogen (FBG), C-reactive protein (CRP), TNF-α, IL-6, α2 macroglobulin
    3) Forced expiratory volume in 1 second (FEV1)
    4) Plasma levels of EP395
    5) St George’s respiratory questionnaire (SGRQ) and Exacerbations of COPD tool (EXACT)-respiratory symptoms (E-RS)


    Exploratory end points:
    6) Blood biomarkers including SP-D, thymic stromal lymphopoietin (TSLP), Clara cell protein (CC)-16, Krebs von den Lungen (KL)-6, MMP-7, cancer antigen (CA)19-9, CA125, soluble cluster of differentiation (sCD)163, sCD14
    7) Bronchial brushing (gene expression including KIAA1177/CEMIB) and lavage including cells (total and differential), TNF α, IL-6, IL-1β, IL-8, MIP-1α, MIP-1β, MCP-1, SP-D, GM-CSF, IL 23, IL-33, IL-25, IL 10, albumin, and protein (and optionally: gene expression in bronchoalveolar lavage [BAL] cells)
    8) Polyinosinic:polycytidylic acid (poly I:C) stimulation of bronchial epithelial cells (BECs)
    9) Microbiome in BAL fluid (BALF), bronchial brushing samples and sputum (if sufficient sample available)




    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Screening, D1, D42, D70, D84
    2) D1, D42, D84
    3) Screening, D1, D28, D56, D84
    4) D14, D28, D42, D56, D70, D80, D84
    5) SGRQ: Screening, D1, D28, D56, D84; E-RS: daily throughout study participation

    Exploratory end points:
    6) D1, D42, D84
    7) D-05, D80
    8) D-05, D80
    9) D-05, D80
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-24
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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